DE69630695T2 - Expandable endovascular stent - Google Patents

Expandable endovascular stent

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Publication number
DE69630695T2
DE69630695T2 DE69630695T DE69630695T DE69630695T2 DE 69630695 T2 DE69630695 T2 DE 69630695T2 DE 69630695 T DE69630695 T DE 69630695T DE 69630695 T DE69630695 T DE 69630695T DE 69630695 T2 DE69630695 T2 DE 69630695T2
Authority
DE
Germany
Prior art keywords
cell
body
angle
characterized
stent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE69630695T
Other languages
German (de)
Other versions
DE69630695D1 (en
Inventor
Munk Palle HANSEN
Zaza Alexandrovich Kavteladze
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
William Cook Europe ApS
Cook Inc
Original Assignee
William Cook Europe ApS
Cook Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to DK099595A priority Critical patent/DK171865B1/en
Priority to DK99595 priority
Application filed by William Cook Europe ApS, Cook Inc filed Critical William Cook Europe ApS
Priority to PCT/DK1996/000375 priority patent/WO1997009945A1/en
Application granted granted Critical
Publication of DE69630695D1 publication Critical patent/DE69630695D1/en
Publication of DE69630695T2 publication Critical patent/DE69630695T2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough

Description

  • The The present invention relates to an expandable endovascular Stent, which comprises a flexible, longitudinal axis, tubular body, the wall of interconnected, closed frame cells there, at least two cells adjoining one another in the circumferential direction lie, the frame cells at least two elongated, mutually converging Have cell sides, the body contains a filament-like frame material that is capable of moving continuously from a frame cell directly into the one closest to it in the longitudinal direction Frame cell extending compressive forces in the axial direction of the To transfer filaments the stent being expandable from a pressed state into one larger diameter showing condition can be brought.
  • Such a stent is from German Patent No. 33 42 798 (corresponding US-A-4 954 126), in which the frame cells stand out opposing Spiral through the body extending wire sets be formed. The frame cells are rhombus-like and the length of the Stents changed significantly in the expansion, which causes several disadvantages as the. Difficulty placing the stent exactly, or that complexity of the induction system.
  • The EP 0 566 807 describes a stent body with rhombic cells. The stent again assumes a reduced diameter and a greater length when the ends of the stent are pulled apart. From WO 92/16166 a vascular prosthesis made of a braided structure is known. The toothed yarns in the structure cannot transmit the compressive forces in the axial direction of the yarn.
  • The US Patent No. 5,370,683 describes a stent consisting of one Single filament wrapped around a mandrel on a corrugated layer, which alternately has short and long elongated parts of the filament, is wound, whereupon the filament on a spiral layer is aligned with the shaft passage. Then were the wave passages interlocked to form rhombic frame cells that a pair opposite short cell sides and a pair of opposite long cell sides exhibit. Among other things, this stent is characterized by its ability from coming under pressure into a radially compressed state without having to pull the ends apart. The stent can be radial compressed state placed in a catheter and inserted and at the desired one Site in a lumen such as a blood vessel, whereupon the catheter pulled out and the stent by means of one inside inflatable balloons attached to the stent can. It is a disadvantage of the stent that it has a relatively poor flexibility in bending, although this is adaptability of the stent to the supported flexible vessels diminished. It is also not an advantage that the cells of the stent are relatively open lie and consequently the fibrous overgrowth into the inner lumen exposed to the stent.
  • In A tubular stent body is made from a stent known from EP-A 645125 a single, bent at an angle, wound in a spiral shape, Filament, the vertices of which are hooked together to form a to form a rhombus-like cell. Because the vertices are only hooked together, there is a risk of compression the stent in the longitudinal direction, when pushed out of the catheter becomes. The two ends of the filament are passed through the filament body brought back in a spiral-like layer, but do not inhibit the risk of length changes in the part of the stent that is outside the end of the catheter extends. It may therefore be necessary to use a stent Traction device that runs centrally through the stent body and that the compression confined in the catheter, pull out of the catheter. The bending flexibility of the stent is also relatively poor and the cells are pretty open.
  • A Variety of different stents of another type in which the cell material not continued directly from one frame cell to the next in the longitudinal direction is known. Instead, this type of stent is made up of several z-shaped bent wires formed by means of connecting threads or by interlocking be assembled into a tubular body, see EP-A 622088, EP-A 480667, WO 93/12825 and EP-A 556850. They all have stents limited bending flexibility and some of these are very complex to manufacture. The connecting thread limit to connect the z-bend, elastic frame material the expanded stent diameter, but give the axial pressure completely after. This gives rise to the considerable disadvantage that influences the cell does not match the lengthways next broadcast is opened so that the stent has interrupted properties and will show breaks under bending.
  • Stents, which are made to form closed cells from wound wires, are known from DE-A 39 18 736, in which the cells are elongated or Ω-shaped and from WO 94/03127, in which the cells are oval in the circumferential direction.
  • task of the invention is to provide a stent that is compressible and is radially expandable without any significant change the length of the body and which has a frame structure that gives the stent greater, uniform flexural flexibility and therefore greater vascular adaptability has. It is also an object of the invention that the stent of the further a compression strength of suitably sized.
  • This the stent according to the invention is in view characterized in that in the expanded state of the stent A heart-shaped or filament in at least some of the frame cells arrow-shaped Cell shape with two opposite arranged and interconnected shorter cell sides that with the two mutually converging longer cell sides connected are, and that the the shorter and longer cell sides forming filaments around each other at the adjacent ends of the pairs the shorter one and longer Cell sides are wrapped.
  • In its expanded state around each other ensures that the stent has a stable shape in which the frame cells not exposed to external loads in relation to each other slip. The winding of the filaments on the adjacent ones Ends secures the frame cells to each other, but at the same time provides an advantageous option bending the filaments apart by opening the turns when the Radially compressed stent is what reduces the filament load at the connection points. A result of the geometric created by wrapping around it Securing the common position of the cells is that in his compressed state of the stent has increased axial rigidity, so that it looks smooth and without changes in length The catheter can be removed when the catheter is withdrawn becomes. The stent made from filaments is relatively easy to manufacture.
  • In the heart-shaped or arrow-shaped Design shows the connection point between the two shorter cells towards the connection point between the two longer cell sides the same cell. Among other things, this includes the handsome Advantage that when the axis of rotation of the stent is bent, the cells on the outside the curvature be deformed so that the angle between the the two shorter ones Cell sides becomes smaller and the cell opens further with a longer cell length. This can occur at a very small bending moment because of the cell expand without simultaneously contracting the surrounding cells can. The smaller angle between the shorter cell sides increases to at the same time the load in the circumferential direction and neutralized the reduction in the radial compressive force of the stent on the outer side the curvature, which is caused here by the lower cell density. The height bending flexibility of the stent and its ability even with severe curvature its longitudinal axis a considerable one radial compression strength to keep the stent to a large vascular compatibility and enable an arrangement of the stent in areas with vascular curvature or other vascular variations and neutralize long-term damage to the Vessel wall.
  • The many closed cells give the stent evenly distributed uniform properties and the cell shape or cell designs are relatively dense, resulting in re-stenosis or other lumen reductions in the vessel are neutralized.
  • at radial compression of the stent folds the longer cell sides together around the shorter cell sides. When fully compressed around a guide wire, the stent has a configuration in which the cell sides are packed tightly around the longitudinal axis of the stent are and extend substantially parallel to it. This poses an advantageous option the placement of the stent in a small internal diameter catheter For example, a stent with a diameter of 8 mm for placement in a catheter with an internal lumen of 7 French (approx. 2.3 mm) compressed become.
  • With With a suitable choice of stent material, the stent can self-expand be when the catheter introduces the compressed stent following is removed. The self-expandability is mainly through get the bending load that comes close when bending the cell sides the ends of which occur. The result of the frame cell design is that bend normally at six points in the cell instead of four points occurs in the rhombic cell and therefore the stent a more even and can have finer distribution of the expansion forces. alternative or as a supplement the stent can be expanded using an inflatable balloon. The self-expanding stent does not have to go radially around a balloon can be compressed and therefore during the introduction in a thinner one Catheters are arranged.
  • At the Folding the frame cells together will turn the cell sides into neighboring ones Cells placed without this lengthways of the stent. This means that with the change between the folded and expanded state of the stent, aside from a negligible change in length at the end of the stent where the cell sides are not in the adjacent Cells are placed, essentially unchanged in length. The stable length is When arranging the stent, this is an advantage since it is released can be arranged exactly in the vasoconstriction. If the catheter is pulled out and the stent is released, the Frame cells to their final Position in contact with the vessel wall almost without some length shift expand the ends of the stent. Consequently, the delivery system have a simple design and be extremely easy to use. The only requirement is a push button that is pulled out while pulling out the Catheter in stationary Contact with the one closest to the insertion opening End of the compressed stent. The simple introduction system reduces the risk of improper stent placement and is quick to use.
  • How previously mentioned becomes the body formed from several filaments, the shorter and the longer cell sides shape and those at the adjacent ends of the pairs at shorter or longer Cell sides are wrapped around each other. In a preferred design each filament has a stepped, spiral layer or a stepped wavy Layer in the longitudinal direction of the body on. The layer of filaments through the body can be selected so that the stent is both rotationally stable and pressure-stable, such as Example through the filaments that have a spiral or undulating layer exhibit.
  • The tubular body can have cell connections in which pairs of filaments are around a rotation around one another in a first direction Axis of rotation and at least one rotation around a second, at a preferably 90 ° angle axis of rotation standing to the first axis of rotation are wound. This kind rotation of the pairs of filaments on the cell junctions a kind of double securing of the filaments with the result that the tubular body an additional Stiffness is maintained at the cell connection, leaving the periphery of the body and even the frame surface is maintained even when the two ends of the body are apart be pulled away. This can be an advantage if the stent is removed after it has been placed in it.
  • It is possible, arrange the heart positions at an oblique angle so that they along a spiral Line into the periphery of the body point. Show with regard to the compact compression of the stent the arrowheads or hearts preferred in the longitudinal direction of the body, and the interval between two adjacent frame cells with the same Alignment of the arrowheads or heart locations consists of a frame cell with opposite Alignment with the arrowhead or heart. The connection between neighboring cells in this design extend lengthways of the stent.
  • In a preferred design have in an annular row in the circumferential direction of the body mutually adjacent frame cells aligned alternately to arrowheads or heart spots and form along the Length of body repeating frame pattern. The run in this design Connections between neighboring cells in a comprehensive Row that is in axial extension of the arrowheads or points in the next to catch Row expanded and all frame cells have the advantageous shape, the uniform properties of the stent, such as even turning, Bends rigidity and compression stiffness.
  • The Cells can itself in a spiral Pattern along the length of the body through both the shorter ones Cell sides as well as the longer cell sides that are mutual different lengths exhibit, expand. However, the two shorter ones and the two longer ones Cell sites preferred considering stent fabrication always the same length on.
  • The first angle between the two longer ones Cell sides are circumferential along with the number of cells of the body aligned and determines the bending stiffness of the body. With the same number of cells in an annular row forms a second Angle a greater distance between the cells in the longitudinal direction and therefore has greater bending stiffness and a more open one Frame structure. The first angle is in the range of 20 to 160 °. If the first angle is less than 20 °, the stent can only be used to a slightly larger extent than in the compressed Expand state. If the first angle is larger than 160 °, large circumferential changes can occur can be achieved, but the number of cells in the longitudinal direction becomes disadvantageous large. The first angle is preferably in the range between 60 to 120 °, which is a advantageously large flexibility combined with a suitable number of cells in the longitudinal direction brings with it.
  • Set the case that the arrowheads or dots are not circumferential show, the second angle pointing into the cell affects between the two shorter ones Cell sides the body's compression stiffness, the density of the frame structure and the additional Increase in diameter, which the body be exposed to a greater extent after normal expansion can. Such an additional one Diameter increase in an overexpanded one For example, condition can be quite beneficial if a self-expandable Stent was inserted into a vessel in which re-stenosis occurs. Following the re-stenosis diagnosis an inflatable balloon can be inserted into the stent and become a larger diameter be inflated without the stent having to be removed, whereby the stent is only overexpanded by the balloon will return to its normal shape after removal of the balloon to return. The possibility of overexpanding can also be introduced of the stent can be used because the balloon has a violent stenosis can be arranged before the balloon expands. In the later Balloon expansion helps the stent to keep the most violent stenosis area away, when the balloon is removed. This avoids expansion before the stent has been positioned. When overexpanding it is a considerable Advantage that the stent has its length while the expansion doesn't change.
  • If the points of the heart-shaped or arrow-shaped Frame cells show circumferentially, the second angle may suitably be at 180 °. If the dots are lengthways show, the second angle should be greater than 184 ° so that the shorter ones Arms are folded in the cell when the stent is compressed. If the second angle is greater than Is 340 ° and the filament is not a big one Has diameter, there is hardly any compression stiffness. preferred The second angle is in the range between 210 to 320 °, which is a suitable compression stiffness, good cell density and the possibility for overexpanding in a considerable larger diameter brings with it. The angles are chosen so that the field of the concerned Application is being considered. The closer the second angle is to 180 °, around so higher is the stent's compression stiffness, but when the angle is considerable becomes smaller than 210 °, becomes the possibility for overexpanding less cheap.
  • In The longer cell sides form a particularly preferred design as well as the shorter cell sides an angle between 10 ° and 45 ° in the longitudinal direction of the body. this makes possible simple compression of the stent, either manually or by To press of the stent through a funnel-shaped Beladebogen. It is particularly beneficial if the longer cell sides in the longitudinal direction at an angle between 40 ° and Stand 45 °.
  • It is possible, the stent thereby greater flexibility in certain Giving areas by the first angle in the frame cells in an area of the body is smaller than in other areas of the body. This can be used to make the stent more flexible around the ends, for example make so the transition from the area of the vessel wall affected by the stent to the unaffected area is what the vascular wall so as low as possible influenced at the stent ends will and vascular injuries and tissue ingrowth is counteracted. This is particularly advantageous since the risk of stent migration in the vessel is low.
  • It is further possible design the stent so that the second angle in the frame cells in an area of the body is bigger than in another area of the body, increasing the compression strength of the Stents can be varied as desired. In case of severe stenosis for example, the second angle may be larger in the end regions of the body, making the stent its largest radial Exert pressure in the middle and the ends are smoother and more adaptable to the vessel. It can also be desirable be that the stent by exercise a strong contact pressure is applied to the end areas and that in In this case, the second angle is then smaller than in the middle of the stent.
  • In in some applications it is desirable that the stent is bell-shaped or has hourglass-like shape that can be obtained by having the shorter and longer cell sides on at least one end of the body the frame cells have a greater length and / or the frame cells form a smaller angle between the shorter cell sides exhibit what the body a larger diameter at the ends than in the middle.
  • With regard to the compression of the stent to an advantageously small external diameter, it can be advantageous that the number of wires in the stent is not too high. If the stent is to be inserted using a small diameter catheter, the number of frame cells in an annular row in the circumferential direction of the body preferably corresponds essentially to the radius of the body, measured in mm. "Essentially" in this context means that for every 4 mm radius the number of cells can be more or less than the measured radius in mm; that is, one more cell or less for a stent with a diameter of 6 mm, two more or less for a stent with a diameter of 10 mm, etc.
  • Examples for designs of a stent according to the invention are detailed below with reference to the very schematic Descriptions described, where:
  • 1 and 2 show plan views of an unfolded part of a stent wall with a cell geometry according to the invention;
  • 3 FIG. 3 shows a view of a design according to the invention, in which the frame cells have the same shape as in FIG 1 and the stent was made from several tortuous filaments;
  • 4 part of the illustration 3 is a stent having a denser frame structure;
  • 5 Figure 3 is a side view of a whole stent design in accordance with the invention;
  • 6 and 7 Are outlines of two unfolded frame parts that represent the effect of varying the angle between the two shorter sides of the frame;
  • 8th and 9 corresponding are outlines representing the effect of varying the angle between the two longer sides of the frame; and
  • 10 is a top view of a particular type of filament turn pairs at cell passages.
  • In the following description of non-limiting examples of designs the invention will be the same in the various designs Reference numbers for equivalent elements used.
  • 5 shows a stent in the form of a tubular body ( 1 ) which consists of several filaments or heart-shaped frame cells ( 2 ) there are bent wires which are wound around one another at the points where the cell filaments meet, so that the frame cells are firmly connected to one another both in the longitudinal and in the circumferential direction.
  • 1 shows an example of a heart-shaped frame cell ( 2 ). Each frame cell ( 2 ) has two mutually converging longer cell sides ( 3 ) at the heart sites ( 4 ) converge into a unified filament and delimit a first angle (α) pointing into the cell. The frame cell also has two shorter cell sides ( 5 ) that converge towards each other in order to 4 ) point surface to be standardized. The shorter cell sides delimit the second angle (β) pointing into the cells and are compared to the longer cell sides ( 3 ) with which you can pass through two side parts ( 7 ) are connected to form the closed frame cell made of pressure-resistant material. The length of the side parts ( 7 ) can be made larger or smaller depending on whether the cell should be opened more or less without changing the sizes of the first or second angle (α, β). The shape of the side part ( 7 ) can also be changed; For example, it may be thin, hourglass-shaped, I-shaped, O-shaped, or any other shape. The straight shape shown with a greater thickness than that of the cell sides ( 3 . 5 ), however, because of their simplicity and the relatively high stiffness, especially when any cell deformation occurs in the cell sides ( 3 . 5 ), prefers. The heart station ( 4 ) can be rounded and the apex area ( 6 ) can be more pointed or rounded than shown. It is also possible to insert a connecting part between two mutually converging cell sides, so that the cell shape becomes angled, for example, without having correct apex regions. In the context of the invention, a heart-shaped or arrowhead-shaped shape means a closed cell which has a pointed shape pointing out of the cell at one end and a more or less pointed shape pointing into the cell at the opposite end.
  • The frame pattern is constructed in such a way that in the circumferential direction of the body there is an annular series of closed, through the common side parts ( 7 ) connected frame cells ( 2 ) whose positions ( 4 ) point similarly in the longitudinal direction of the body. The longer cell sides ( 3 ) also form corresponding sides in a ring-shaped adjacent row in the longitudinal direction of the body, which consist of uniformly formed closed frame cells with opposite orientation of the point ( 4 ) consist. These two rows of cells form a similar row of cells in which the sites ( 4 ) alternately have opposite orientations and continue the common side parts of the later series. The stent length can be the desired application can be adapted by changing the number of annular cell rows.
  • In the preferred embodiment shown, the first angle (α) is approximately 90 ° and the second angle (β) is approximately 263 °. This gives the stent advantageous uniform properties for both the bending and the compression strength, because the longer cell sides ( 3 ) and the shorter cell sides ( 5 ) all form an angle of approx. 45 ° to the longitudinal direction of the body. With radial compression of the stent, the cell sides are therefore deformed and the load is evenly distributed over the sides of the cells, which, when expanded, leads to uniformly strong unfolding of all cells with little risk of false unfolding and a uniform, resulting pressure influence on the vessel wall. Because the second angle (β) is smaller than the angle (360 ° -α) corresponding to a line parallel to the shorter and longer cell sides, the free distance between the apex area ( 6 ) and the place ( 4 ) a suitable size so that when compressed, the side part ( 7 ) This can be received more easily by the later frame cell of the same orientation if swinging backwards and in the direction of the longitudinal axis of the body. This promotes the compact compression of the stent.
  • In the 2 The design shown differs in the form that some of the cells do not have the advantageous heart-shaped or arrowhead-shaped shape because a number of rhombic cells ( 8th ) were inserted into the cell pattern. This gives the stent an area with more open cells and considerably greater flexural rigidity, which can be used, for example, to stabilize undesired large local vascular movements. Of course, it is also possible to give the individual local cells a different shape. This can be done in a simple manner by removing one or more cell sides in a cell.
  • In the design of 3 show the frame cells ( 2 ), the first angle (α) and the second angle (β) have the same dimensions as in 1 , the body ( 1 ) but is by on an axis of rotation around guide pins ( 9 ) curved and once on the side part ( 7 ) filaments wound around themselves. Due to the structure of the filaments, the cells have rounder shapes and the heart-shaped shape can take on a heart shape. For each frame cell ( 2 ) two filaments extend in a circumferential row ( 10 . 11 ) from one end of the stent, with the filaments as one filament end ( 12 ) or in an eyelet ( 13 ) can be wrapped around each other. Each pair of the two filaments extends from the frame cells at the ends of the stent ( 10 . 11 ) along the body in a stepped spiral line with opposite winding direction, in which the filaments one of the shorter cell sides ( 5 ) are wound around the corresponding filament of the neighboring cell in the same row, run as a longer cell side ( 3 ) in this frame cell, are wound around the second filament of this cell, run as the shorter cell side ( 5 ) in the frame cell in the later row and so on until the end at the other end of the stent. If, at equal intervals, the filament is wound a half turn more or less around the oppositely extending filament, the filament line will change from spiral to undulating. The appearance of the frame cells can be changed by changing the position and the number of guide pins ( 9 ) be changed as desired; the cell shape can, for example, in the structure of the description for 1 and 2 be modified. Efforts are being made to ensure that the longer cell sides ( 3 ) and the shorter cell sides ( 5 ) as far as possible a straight line between the curvatures on the guide pins ( 9 ), but in practice the cell sides can be S-shaped or any other curved line. 4 shows an example of a varied cell shape in which the first angle (α) is approximately 120 ° and the second angle (β) is approximately 253 °. It can also be observed that the side parts ( 7 ) are shorter due to a lower degree of winding. If longer side parts are desired, the filaments can be wrapped around each other several times. Instead of wrapping the filaments around each other, the connections between the frame cells can be rings or threads that close the two adjacent filaments together. Another cell shape is in 5 shown, in which the first angle (α) is 70 ° and the second angle is approximately 322 °. Such a design can be advantageous if the filament diameter is relatively large and the filament is therefore less flexible.
  • In comparison, the two in 6 and 7 shown designs, the influence of the second angle (β) on the cell shape can be seen if the cell width, the first angle and the length of the side part ( 7 ) in relation to the design of 3 remain unchanged. In 6 the second angle (β) is approximately 184 ° and in 7 approx. 275 °. In 6 the frame structure is open and the shorter cell sides form slightly curved, ring-shaped strips that 1 ) give high pressure rigidity. In 7 the frame structure is very dense and allows the body to overexpand generously.
  • In comparison, the two in 8th and 9 Shown designs to see the influence of the first angle (α) on the cell shape when the cell width, the second angle and the length of the page partly ( 7 ) in relation to the design of 3 remain unchanged. In 8th the first angle is approx. 62 °, while this is in 9 is approximately 120 °. In 8th the cells have a wide open structure. In 9 the structure is very dense, but the number of wires is also large compared to the length of the stent.
  • The Stent material is preferably Nitinol, which has excellent elastic properties and has large deformations he wears. Alternatively, you can Stainless steel, titanium, copper alloys, tantalum or other biological compatible materials that maintain the expanded state in the vessel can, or mixtures of such materials can be used. If the stent balloon-expanded when placed in the vessel stainless steel can be just as suitable as nitinol. It is the other possible a synthetic material as a stent material such as modified Butandine or other synthetic materials with good elastic Properties to use.
  • The cross-sectional area of the cell sides is selected on the basis of the desired diameter, the desired stiffness and the cell shape in the stent, a larger cross-sectional area being used for larger diameters, for a greater desired stiffness and / or for more open cells or a smaller number of cells. If the in 3 As shown in the frame design for a stent for use in the Iliac, the stent may be, for example, 8 mm in diameter, there may be four cells in each annular row and the filament may be, for example, a 0.16 mm diameter nitinol wire. A corresponding stent can be used in biliary strands whose lumens have been reduced by tumors or fibrosis. Stents can also be used to expand the esophagus in patients suffering from malignant dysphagia, to enlarge the urethra or other body vessels. An extremely important field of the invention is stents for dilating blood vessels or for maintaining expanded vasoconstrictions, such as in severe stenosis. The following list mentions examples of applicable stent diameters, etc., for various applications.
  • Figure 00190001
  • Figure 00200001
  • The Filament diameter or thickness / width of the cell sides are on the Adjusted stent diameter, the cell sides with smaller stent diameters a smaller cross-sectional area is given. For example, the filament diameter can be in the interval from 0.06 to 0.40 mm.
  • If the tubular body is formed from several filaments, these filaments can be attached to the cell connections in a different way than in 3 shown to be wrapped around each other. In 10 the turn is designed as if a kind of knot ( 130 ) is formed. At the cell connection are the two filaments ( 104 . 105 ) with a rotation about an axis of rotation extending in a first direction ( 131 ) wound around each other and then the filaments are in the direction of a second axis of rotation which extends at an angle of preferably approximately 90 ° to the first direction ( 132 ) wound around each other with at least one turn. The first direction can extend approximately in the circumferential direction to the tubular body stretch and the second axis of rotation can then extend approximately in the longitudinal direction to the tubular body.
  • It is possible, the stent with a coating on at least part of the peripheral Surface of the to equip tubular body. The case is impermeable to blood and can be a net or a shell a suitably dense material such as Dakron, PTFE or others suitable biocompatible materials. The stent provides with its Coating represents a graft that is used as an artificial vessel can be. The use of a graft is in the field well known and needs no further explanation. The stent according to the invention is because of its uniform properties and his great ability an obvious vascular lumen despite maintain considerable bending or local radial pressure loads, for a Graft particularly suitable.

Claims (18)

  1. Expandable endovascular stent that has a flexible, longitudinal axis tubular body ( 1 ), whose wall consists of interconnected, closed frame cells ( 2 ), with at least two cells lying adjacent to one another in the circumferential direction, the frame cells ( 2 ) have at least two elongated, mutually converging cell sides, the body contains a filament-like frame material, which is able to continuously transmit compressive forces in the axial direction of the filament from a frame cell directly into the frame cell closest in the longitudinal direction, the stent being expandable from a pressed one State can be brought into a state with a larger diameter, characterized in that in the expanded state of the stent, the filaments in at least some of the frame cells ( 2 ) from a heart- or arrow-like cell shape with two interconnected, shorter cell sides ( 5 ) with the two mutually converging, longer cell sides ( 3 ) are arranged opposite and connected, and that the filaments forming the shorter and longer cell side ( 10 . 11 ) around each other, at the adjacent ends of the pairs on shorter and longer cell sides.
  2. Expandable endovascular stent according to claim 1, characterized in that the single filament ( 10 . 11 ) a stepped, spiral or a stepped, undulating layer in the longitudinal direction of the body ( 1 ) having.
  3. Expandable endovascular stent according to claim 1 or 2, characterized in that the tubular body ( 1 ) Has cell connections where pairs of filaments ( 10 . 11 ) around a rotation around a first axis of rotation extending in a first direction and at least around one rotation around a second axis of rotation at an angle to the first axis of rotation.
  4. Expandable endovascular stent according to claim 3, characterized in that the second axis of rotation at an angle of about 90 ° to first axis of rotation.
  5. Expandable endovascular stent according to claim 3 or 4, characterized in that the first direction approximately in the circumferential direction The direction of the tubular body is and that the second axis of rotation is roughly longitudinal of the tubular body.
  6. Expandable endovascular stent according to one of claims 1 to 5, characterized in that the arrows or heart sites ( 4 ) in the longitudinal direction of the body ( 1 ) and that the interval between two neighboring frame cells has the same orientation as the arrows or heart locations ( 4 ) from frame cells with opposite orientation like the arrows or heart positions ( 4 ), consists.
  7. Expandable endovascular stent according to one of claims 1 to 6, characterized in that the in an annular row in the circumferential direction of the body ( 1 ) neighboring frame cells ( 2 ) alternating arrows or heart positions ( 4 ) and form a repeated frame pattern along the length of the body.
  8. Expandable endovascular stent according to one of claims 1 to 7, characterized in that two shorter cell sides ( 5 ) have essentially the same length and that the longer cell sides ( 3 ) have the same length.
  9. Expandable endovascular stent according to claim 8, characterized in that the shorter cell sides ( 5 ) essentially parallel to the longer cell sides ( 3 ) run.
  10. Expandable endovascular stent according to one of claims 1 to 9, characterized in that a first angle (α) between the two longer cell sides ( 3 ) and aligned in the direction of the cell in the interval from 20 ° to 160 °, and that a second angle (β) between the two shorter sides of the cell ( 5 ) and aligned in the direction of the cell in the interval from 184 ° to 340 °.
  11. Expandable endovascular stent according to claim 10, characterized in that a first angle (α) between the two longer cell sides ( 3 ) and aligned in the direction of the cell in the interval from 60 ° to 120 °, and that a second angle (β) between the two shorter sides of the cell ( 5 ) and aligned in the direction of the cell in the interval of 210 ° to 320 °.
  12. Expandable endovascular stent according to one of claims 10 or 9, characterized in that the longer cell sides ( 3 ) and the shorter cell sides ( 5 ) all at an angle of approximately 10 ° and 45 ° to the longitudinal direction of the body ( 1 ) form.
  13. Expandable endovascular stent according to one of claims 10 to 12, characterized in that the longer cell sides ( 3 ) form an angle between 40 ° and 45 ° with the longitudinal direction.
  14. Expandable endovascular stent according to one of claims 1 to 13, characterized in that the first angle (α) in the frame cells ( 2 ) in an area of the body ( 1 ) is smaller than in another area of the body.
  15. Expandable endovascular stent according to one of claims 1 to 14, characterized in that the second angle (β) in the frame cells ( 2 ) in an area of the body ( 1 ) is larger than in another area of the body, and that the second angle (β) is preferably larger in the end area of the body.
  16. Expandable endovascular stent according to one of claims 1 to 15, characterized in that in at least one end of the body ( 1 ) the shorter and longer cell sides ( 3 . 5 ) the frame cells ( 2 ) a greater length and / or a smaller angle (β) between the smaller cell sides ( 5 ) than in the middle of the body, which gives the body a larger diameter at the ends than in the middle.
  17. Expandable endovascular stent according to one of claims 1 to 16, characterized in that the number of frame cells ( 2 ) in a tubular row in the circumferential direction of the body ( 1 ) corresponds essentially to the radius of the body, measured in mm.
  18. Expandable endovascular stent according to one of claims 1 to 17, characterized in that the tubular body ( 1 ) is provided with a blood-impermeable coating on at least part of its peripheral surface.
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EP0850032B1 (en) 2003-11-12
DE69637173D1 (en) 2007-08-30
JP3714959B2 (en) 2005-11-09
CZ289423B6 (en) 2002-01-16
PL325463A1 (en) 1998-07-20
EP1266636B1 (en) 2007-07-18
DE69637173T2 (en) 2007-12-06
EP1266636A2 (en) 2002-12-18
WO1997009945A1 (en) 1997-03-20
PL183920B1 (en) 2002-08-30
ES2210383T3 (en) 2004-07-01
HU9901058A2 (en) 1999-07-28
JPH11512306A (en) 1999-10-26
RU2257180C2 (en) 2005-07-27
AU6786196A (en) 1997-04-01
AU712001B2 (en) 1999-10-28
DK99595A (en) 1996-02-08
JP2004073876A (en) 2004-03-11
CN1201380A (en) 1998-12-09
DK171865B1 (en) 1997-07-21
CZ71598A3 (en) 1998-06-17
JP3886951B2 (en) 2007-02-28
DE69630695D1 (en) 2003-12-18
CN1131017C (en) 2003-12-17
AT253878T (en) 2003-11-15
EP1266636A3 (en) 2004-01-07
HU9901058A3 (en) 1999-11-29
AT367133T (en) 2007-08-15
DK0850032T3 (en) 2004-03-22
US5928280A (en) 1999-07-27
RU2175531C2 (en) 2001-11-10
EP0850032A1 (en) 1998-07-01
HU220476B1 (en) 2002-02-28

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